Clinical trials: Bypass Surgery
Coronary Arteriosclerosis, Atrial Fibrillation
A(f)MAZE-CABG Study
Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG…
- Conditions
- Coronary Arteriosclerosis, Atrial Fibrillation, Coronary Artery Bypass Graft Surgery
- Trial name
- AFMAZE-CABG (NCT00735722)
- Testing
- HIFU AF Ablation
- Where
- 10 sites in Canada, Finland and 4 more
- Volunteers
- 188 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI.
- Trial name
- NCT02496234
- Where
- United States
- Volunteers
- 186 people
- Sponsor
- Sapere Bio
Hypotension, Cardiopulmonary Bypass
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients
The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.
- Trial name
- NCT00482287
- Testing
- MTR105
- Where
- United States
- Sponsor
- Meditor Pharmaceuticals Ltd.
Subjects With Primary Open-angle Glaucoma (POAG)
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.
- Trial name
- NCT01252888
- Testing
- iStents
- Where
- Armenia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Glaukos Corporation
Aortic Valve Disease, Coronary Artery Disease (CAD)
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery.
- Trial name
- Custodiol-AV (NCT02098772)
- Testing
- Custodiol-N, Custodiol
- Where
- 6 sites in Germany
- Volunteers
- 530 people
- Sponsor
- Dr. F. Köhler Chemie GmbH
Cardiac Surgery, Heart Surgery
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety.
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery
- Trial name
- NCT07354841
- Testing
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Eurosets S.r.l.
Acute Lung Injury
L-citrulline for Prevention of Sequelae of Acute Lung Injury in Pediatrics Undergoing Cardiopulmonary Bypass for Heart Defects
The purpose of this study is to determine whether L-citrulline is effective and safe in the prevention of clinical sequelae of Acute Lung Injury in pediatric subjects undergoing surgery for congenital heart defects.
- Trial name
- NCT02891837
- Testing
- L-citrulline
- Where
- 29 sites in United States, Austria and 2 more
- Volunteers
- 189 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Coronary Artery Disease
Prevention of Autogenous Vein Graft Failure in Coronary Artery Bypass Procedures
The purpose of this study is to determine the efficacy of graft pretreatment with CGT003 (E2F Duplex Decoy), as compared to placebo, on the incidence of patients experiencing vein graft failure after coronary artery bypass…
- Trial name
- NCT00042081
- Testing
- CGT003 (E2F Duplex Decoy)
- Where
- 154 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Anesiva, Inc.
Off Pump Coronary Artery Bypass Surgery
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery.
- Trial name
- NCT07286890
- Testing
- Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Maquet Cardiovascular
Open-Angle Glaucoma
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with…
- Trial name
- NCT00326066
- Testing
- Glaucoma Surgery, cataract surgery only
- Where
- 9 sites in Austria, Germany and 3 more
- Volunteers
- 47 people
- Sponsor
- Glaukos Corporation
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in…
- Trial name
- NCT00154427
- Testing
- activated recombinant human factor VII
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 172 people
- Sponsor
- Novo Nordisk A/S
Bloodloss, Surgical Procedures, Operative
A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume
The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.
- Trial name
- CONSERV-1 (NCT00816023)
- Testing
- ecallantide
- Where
- 29 sites in United States, Canada
- Volunteers
- 276 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Cardiopulmonary Bypass Surgery
HPI (Hypotension Prediction Index) Care Trial
A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients…
- Trial name
- NCT05083403
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Edwards Lifesciences
Coronary Heart Disease, Graft Occlusion, Vascular
A Study of RO4905417 in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This randomized double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in the prevention of saphenous vein graft disease in patients undergoing elective or urgent coronary artery bypass (CABG)…
- Trial name
- NCT01245634
- Testing
- RO4905417
- Where
- 38 sites in United States, Canada
- Volunteers
- 384 people
- Sponsor
- Hoffmann-La Roche
Coronary Artery Disease
Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery
The study has been designed to comparatively evaluate the safety and effectiveness of the PAS-Port Proximal Anastomosis System and conventional suturing techniques for creation of the connection between graft veins and the aorta…
- Trial name
- EPIC (NCT00355563)
- Testing
- PAS-Port Automated Proximal Anastomosis System
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Cardica, Inc
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Ischemic Heart Disease
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG
ADR-002K is administered to heart failure patients with ischemic heart disease who undergo coronary artery bypass surgery (CABG) to investigate its efficacy and safety.
- Trial name
- NCT07192211
- Testing
- Mesenchymal stem cell
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Rohto Pharmaceutical Co., Ltd.
Congestive Heart Failure, Coronary Artery Disease
Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection
MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function.
- Conditions
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- Trial name
- NCT00050765
- Testing
- MyoCell™ Autologous Myoblasts
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Bioheart, Inc.
Obesity, Roux-en-Y Gastric Bypass
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during laparoscopic…
- Conditions
- Obesity, Roux-en-Y Gastric Bypass, Gastrectomy, Mini Gastric Bypass
- Trial name
- STAP-Delta (NCT04422236)
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- Belgium
- Volunteers
- 200 people
- Sponsor
- Duomed
Prevention of Venous Thromboembolism
Efficacy And Safety Of Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Eurofarma Laboratory product when compared to porcine heparin APP Pharmaceutical in…
- Trial name
- NCT01072955
- Testing
- Bovine Heparin, Porcine heparin
- Where
- Brazil
- Volunteers
- 104 people
- Sponsor
- Azidus Brasil